EP Labs

Emerging Technologies in the Cath & EP Labs

Mauricio Arruda, MDJohn R. Antonucci Master Clinician of Cardiovascular Innovation

Director of Electrophysiology Center

UH Harrington Heart & Vascular Institute

Associate Professor of Medicine

Case Western Reserve University

School of Medicine

Ohio-ACC 27th Annual Meeting

Disclosures

Consultant / Speaker / Advisor

• Biosense Webster

• Abbott

• Stereotaxis

No Investigational Technologies

Electrophysiology Center

Electrophysiology Pacing

• EPS

• Ablation

• Cardioversion

• EP Clinics

• Genetics Clinic

• Telemetry – Outpatient

• Research / Clinical Trials

• New Programs

LAA Occlusion

VT / VF – ICU

• Device Implants

• Device Clinics

• Lead Management

Extraction Program

• Clinical Trials

Subcutaneous Event Monitor

Brady TherapiesLeadless Cardiac Pacemaker

1.5T and 3T Full Body MRI Scanning

No restrictions on

– Scan duration

– Number of scans

– R-wave amplitude

– Pacemaker dependency

6

LV Lead Location Matters For Better CRT Outcomes

Subcutaneous ICD

Lead Extraction

CARTO® SMARTTOUCH® Technology

CS

Left Common PV

SVC

SVC

Technologies Arrhythmia Mapping and Ablation

Robotic Magnetic Navigation Arrhythmia Mapping and Ablation

Catheter Ablation for Rhythm Control

Atrial FibrillationNon-Pharmacologic Management

1. Craig T. January, MD, PhD, FACC; L. Samuel Wann, MD, MACC, FAHA; Joseph S. Alpert, MD, FACC, FAHA; Hugh Calkins, MD, FACC,ET AL. 2014 AHA/ACC/HRS Guideline

for the Management of Patients With Atrial Fibrillation: Executive Summary. J Am Coll Cardiol. 2014;64(21):2246-2280

The 2014 AHA/ACC/HRS Guidelines for Afib Management provide the highest level

of recommendation (Class: 1; Level of Evidence: A) for catheter ablation as

treatment for drug-refractory, symptomatic paroxysmal Afib.

ClassRECOMMENDATION

THE STRONGEST RECOMENDATION

1 LevelLEVEL OF EVIDENCE

THE HIGHEST LEVEL OF EVIDENCE

A

Society Guidelines for AF Ablation

Rate vs. Rhythm ControlTimeline

AFFIRM StudyNo survival

advantage of

Rate vs. Rhythm control

2002 2006 20142012

Class

III

Level C

2001

Class II

Level B

Ionescu Mortality among

patients on rhythm

control gradually decreased relative

to rate control

Class I

Level

A*

Ghanbari NSR after RFCA is

associated with

60% reduction in CV mortality

Society Guidelines for Afib Ablation

*Class I Level A for PAF with no or minimal heart disease

2010

Wilber RFCA is superior in

efficacy and safety

to AAD

2004

Corley (AFFIRM sub-analysis)

NSR associated

with 47% reduction on risk of death

2003

DIAMOND Study

NSR leads to

significant reduction in

mortality

2002

✓ Paroxysmal AF 167pts ➢Catheter Ablation: 106➢AADs: 61

✓ PVI 100.0%, CTI 35.9%, Linear Ablation 22.3%, SVC 16.5%, Non-PV trigger 16.5%.

✓ Freedom from recurrence at 9 months.➢Ablation: 66%➢AAD: 16%Log-rank P<0.01

Antiarrhythmic Drugs vs. Ablation (PVI) for Paroxysmal AF

ThermoCool AF

Wilber et al. JAMA 2010;303:333-340.

PVI by Ablation

AAD

B

RSPV

Pre Isolation

A

RSPV

LSPV

RSPV

Post Isolation

C

A B

C D

E F

G H

LSPV Antrum LSPV

LSPV

LIPV

RSPV

RIPV

SCV

CS

EGM-Guided PVI

RSPV

CFAEs and Linear Ablation for Persistent AF

STAR AF II

Verma et al. N Engl J Med 2015;372:1812-22.

✓ Persistent AF 589 pts (PVI: 67, PVI + CFAE: 263, PVI + Roof + Mitral Line: 259)✓ No difference in long-term outcome between the 3 strategies.

Freedom from recurrence at 18 months (Log-rank P=0.15). ➢ PVI : 59%➢ PVI + CFAE : 49%➢ PVI + Roof + Mitral Line : 46%

Left Atrial Fibrotic Substrate Ablation

as an Adjunct to PVI

Persistent AF Mild LVd

LSPV

RSPV

RIPV

LIPV

SVC-RA

CT

CSCS

SVC-RA

CT

PAAP

MA

✓ Patients with localized LVd in the posterior wall. Note mid and lower posterior lines enclosing LVd.

Case Presentation

• 78yo, male Pt with persistent AF

• Miral valvuloplasty (2004)

• Broad low voltage area in the LA on Voltage map

AP PA

ⅡⅠ

V1

RA

ABL 1-2ABL 3-4

LSPV

aVF

CS

AF Termination during Ablation at the LA Roof

ⅡⅠ

V1

RA

ABL 1-2

LSPV

aVF

CS

ABL 3-4

PA

Ventricular Fibrotic Substrate Ablation

VT / VF

VT 7

Arruda et. Al.

Arruda et. Al.

LV and RV Endocardial

Electroanatomic Voltage Mapping

Arruda et. Al.

Endocardial and Epicardial

Electroanatomic Voltage Mapping

Arruda et. Al.

Ablation LV Endocardial

• Frequent VT/VF episodes preceded by a single PVC

• Refractory amiodarone

• EF 25%, global LV hypokinesis

• Circulatory support - Impella

VF Storm – Cardiogenic ShockStatus post CABG and mitral valve repair

ECMO Catheter Ablation

Monomorphic VT (RBBB Morphology and superior Axis)

changed to Fast Polymorphic VT

V1

V2

V3

V4

V5

V6

I

II

III

aVR

aVF

aVL

500ms

Monomorphic VT(RBBB Morphology and superior Axis)

changed to VF

V1

V2

V3

V4

V5

V6

I

II

III

aVR

aVF

aVL

500ms

DC Shock

Elimination of VT/VF After

Fibrotic Substrate Homogenization

RAO

LAO

LV Voltage map

RAO

LAO

Scar Homogenization

V1

V2

V3

V4

V5

V6

I

II

III

aVR

aVF

aVL

VT PM at LV septum

V1

V2

V3

V4

V5

V6

II

III

aVR

aVF

aVL

Intracardiac Echo (ICE)

In The EP Lab

ICE-Guided Pulmonary Vein Electrical Isolation

ViewFlex™ Xtra ICE Catheter

Left / Right

Anterior / Posterior

Trans-Septal Puncture

ICE Assessment of Catheter Contact

Case Presentation76yo, Female, PVC from Anterior Papillary Muscle

Clinical PVC RBBB / Inferior Axis Morphology

V1

V2

V3

V4

V5

V6

I

II

III

aVR

aVF

aVL

500ms

Activation Mapping at the APMPVCSR

-24

V1

III

aVF

RA

ABLd

p

CS

d

p

ICE Imaging to guide Ablation at Pappilary Muscle

V1

V2

V3

V4

V5

V6

I

II

III

aVR

aVF

aVL

V1

V2

V3

V4

V5

V6

I

II

III

aVR

aVF

aVL

500ms

PMPVC

Pace Mapping at the APM

VT during RF Ablation at APM

V1

V2

V3

V4

V5

V6

I

II

III

aVR

aVF

aVL

100ms

Pericardial Effusion Before Transeptal Catheterization

Pericardial Effusion After

Pericardiocentesis

ICE Imaging Miscellaneous

Saline Irrigation - tip of Ablation Catheter

RF Lesion Formation in the LA

During RFA After RFA

Left Atrial Appendage Occlusion Stroke Prevention

Atrial FibrillationNon-Pharmacologic Management

LAA Closure for Stroke Prevention in NVAF

LAA

STROKE

Atrial Fibrillation Clinical Pathway

Atrial Fibrillation

Confirmed by ECG

Stable Patient ? CP, SOB, HF

Oral Anticoagulation

CHADS2-VA2SC ≥1 ?

Warfarin Warfarin

NOACs

LAAO

No

Underlying

Conditions

DM, HTN, HLP, Obesity

Thyroid Disease, OSA,

CAD, Valv ular Disease,

HF

Echocardiogram

TSH

Basic Metabolic Panel

Lipid Panel

Liv er Function Tests

Sleep Study

EmergencyDepartment

Heart Rate Control

Beta Blockers

Diltiazem, Verapamil

Digoxin

✔ Contra-

indications

Target Heart Rate:

Resting 70-110 bpm

Yes

No

Yes

Yes

Restore Sinus Rhythm

Cardiov ersion

Antiarrhythmic Drugs

Flecainide, Propafenone

Dronedarone, Sotalol

Dofetilide, Amiodarone

✔ Contra-indications

Stroke

Risk

Assessme

nt

Stress Test

Exercise, Pharmacologic

Nuclear

Left Heart Catheterization

Catheter ablation Atrial Fibrillation

AV junction + Pacemaker

LA Appendage Occlusion

Electrophysiology / Cardiology

Valv ular Disease

By

Echocardiogram ?

53

LAA Closure Devices

Endocardial

• PLAATO

• Watchman

• ACP

• Amulet

• Coherex

• Prolipsis

• Occlutech

• PFM Medical

• Lifetech

• Cardia• Gore

• SentreHeart

• AEGIS

• AtriCure

• Medtronic

• Maquet

CE, FDACECE - US trial - starting

CE, FDA 510K

CE

Epicardial

Surgical

Cactus (30%) Windsock (19%)Chicken Wing (48%) Cauliflower (3%)

Di Biase et al. JACC 2012, 60: 531-538

LAA Anatomy - LAA were were distributed into 4 morphologies 932 AF patients

• Nitinol frame radially expands to maintain position in LAA

• 10 fixation anchors engage LAA tissue for stability and retention

• Polyethylene terephthalate (PET) membrane designed to block emboli from exiting the LAA

Anchors

160 Micron Membrane

Designed specifically for the left atrial appendage

WATCHMAN LAAC Device Overview

55

Assessment of LAA size for proper device choice

00 900

1350

22mm

20mm

20mm

21mm

LCX

450

a a

Tug test Color Flow around device20% Compression

WATCHMAN™ Device Endothelialization

Canine Model – 30 Day

Canine Model – 45 DayHuman Pathology - 9 Months Post-implant

(Non-device related death)

Images on file at Boston Scientif ic Corporation.

Results in animal models may not necessarily be indicat ive of clinical outcomes.

Procedural Success

Implant success defined as deployment and release of the device into the LAA; no leak ≥ 5 mm* The EWOLUTION Registry is a European prospectiv e registry which reflects CE Mark indications for use which differ from the FDA indications for use.

1 Boersma, L.et al. EHJ; published online Jan 2016 in press; 2 Reddy VY, Holmes DR, et al. JACC 2016; Article in press

~50% new operators ~70% new operators

AMPLATZER™

Amulet™

Device

Lobe▪ Inside the LAA neck

▪ Designed to conformto LAA anatomy

Stabilizing

Wires▪ Engage with LAA wall▪ Help hold the device in place

Waist▪ Maintains tension between lobe and disc

▪ Allows device to self-orient

Disc• Completely seal

at the orifice

“Amulet is an investigational device in the US and not approved by FDA for commercial distribution.”

Amplatzer™ Amulet™

Device Implant Procedure

Measure LAA orifice, landing zone, depth Deploy LOBE in landing zone

Deploy the DISC, to cover the ostium Release

1 2

3 4

“Amulet is an investigational device in the US and not approved by FDA for commercial distribution.”

Coherex WAVECREST LAA Closure Device

Permanent Ligation Approximation Closure and Exclusion

LARIAT® Suture Delivery Device

Bartus K et al. J Am Coll Cardiol 2013;62:108–18.

LARIAT® Suture Delivery Device

Thank You

Emerging Technologies in the Cath & EP Labs

Ohio-ACC 27th Annual Meeting